A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Condition(s) studied
Investigational drug(s) / intervention(s)
Sculptra®: Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.
Study summary
Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.
Eligibility
Primary outcome measure(s)
- Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging — 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline
Images taken with VISIA imaging system and an imaging system using tomography technology at baseline and post-baseline timepoints will be compared to assess structural changes in cheeks.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Luxurgery | New York | New York | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07399028 on ClinicalTrials.gov ↗ ← All trials in the USA